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저지방 다이어트와 저탄수화물 다이어트가 체지방 변화에 미치는 다이어트 순서의 영향

Background:

In a previous study, participants were lived at the NIH and randomly received either a low-fat or a low-carbohydrate diet for 2 weeks and then switched to the other diet for 2 more weeks. Participants who received the low-carbohydrate diet first lost more body fat at the end of the study than those who received the low-fat diet first. Researchers want to see if they can repeat that result in a longer weight loss study when participants live at home.

Objective:

To test the effects of diet order in people receiving either a low-fat or low-carbohydrate diet first for 4 weeks and then immediately switched to the other diet for another 4 weeks.

Eligibility:

Adults aged 19 to 50 years with a body mass index of 25 or more.

Design:

Participants will complete the study at their homes, but there will be 3 required visits to the NIH. Participants will drink a special type of water 2 weeks before the baseline NIH visit and collect urine samples at home to measure how many calories they burn. Before the diets begin, participants will visit the NIH for baseline testing when they will have a metabolism test while relaxing in a bed with a plastic hood over their head to collect the air they breathe out. They will have scans to measure their bone density and how much muscle and body fat they have. They will give stool, blood, and urine samples.

Participants will be asked to eat a specific diet for 4 weeks followed by a different diet for 4 weeks. All meals will be delivered to the participants' homes. They will eat only the foods delivered.

Participants will weigh themselves daily. They will wear a monitor to track their physical activity and a sensor to measure their glucose levels. They will prick their finger each morning to test a drop of blood for ketones. Participants will meet virtually as a group with the study team weekly. Participants will have two more NIH visits towards the end of each diet period....

연구 개요

상세 설명

Study Description:

This is an 8-week crossover outpatient feeding trial of a low carbohydrate versus a low-fat diet, each provided for 4 weeks in random order with no washout period, in adult volunteers with overweight or obesity.

Objectives:

Primary Objectives: To determine the effect of diet order on the mean total fat mass change in subjects randomized to receive either a low carbohydrate followed by a low fat diet or the reverse order, with each diet lasting for 4 weeks.

Secondary Objectives: To determine the effect of diet order on the mean rate of body weight change in subjects randomized to receive either a low carbohydrate followed by a low fat diet or the reverse order, with each diet lasting for 4 weeks and the rate of weight change is measured during the last 2 weeks of each diet. To determine the effect of diet order on mean total body weight change in subjects randomized to receive either a low carbohydrate followed by a low fat diet or the reverse order, with each diet lasting for 4 weeks.

Endpoints:

Primary Endpoint: Mean total fat mass change measured by dual energy X-ray absorptiometry at baseline and week 8.

Secondary Endpoints: Mean rate of weight change by linear mixed modeling of daily weight measurements. Mean total body weight change measured between baseline and week 8.

연구 유형

중재적

등록 (추정된)

42

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Nan Zhai, C.R.N.P.
  • 전화번호: (301) 827-3324
  • 이메일: nan.zhai@nih.gov

연구 연락처 백업

연구 장소

    • Maryland
      • Bethesda, Maryland, 미국, 20892
        • 모병
        • National Institutes of Health Clinical Center
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

  • INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  1. Stated willingness to comply with all study procedures and availability for the duration of the study
  2. Adults aged 18-50 years
  3. Weight stable (< +/- 5% over past 6 months) as determined by volunteer report
  4. Body mass index (BMI) >= 25 kg/m^2
  5. Agreement to adhere to Lifestyle Considerations throughout the study duration

EXCLUSION CRITERIA:

  1. Subjects with cardiac pacemakers or other implants that may be affected by or affect the DXA measurements
  2. Inadequate access to equipment required for the study (e.g., too little refrigerator storage space or a microwave oven that is too small) as determined by discretion of PI and/or study team
  3. Evidence of diseases or conditions that may influence appetite (e.g., cancer, diabetes, alterations of smell or taste post COVID-19), diseases or conditions that affect the immune system, or other conditions at the discretion of the PI and/or study team
  4. Taking prescription medications or other drugs that may influence metabolism (including but not limited to diet/weight-loss medication, some psychiatric medications, or other medications at the discretion of the PI and/or study team)
  5. People unlikely to adhere to a relatively consistent daily and weekly routine and avoid travel during their participation in the study. For example, people with occupations such as pilots, flight attendants, or frequently travel for work or pleasure.
  6. People unlikely to abstain from off study food or supplements that may impact metabolism or appetite at the discretion of the study team
  7. Positive pregnancy test or lactating as determined by volunteer report (women only)
  8. Inability or unwillingness to use birth control between screening and completion of the study (women only)
  9. Symptoms or signs of perimenopause or menopause by volunteer report (women only)
  10. Regular vigorous exercise >150 min per week as determined by volunteer report
  11. Alcohol consumption > 3 drinks per day as determined by volunteer report
  12. Regular use of tobacco (smoking, chewing, or vaping), nicotine replacement therapy, or illicit drugs over past 6 months as determined by volunteer report. Subjects may also be excluded based on a urine drug test.
  13. Psychological conditions as determined by DSM-5 Self-rated Level 1 Cross-cutting Symptom Measure such as (but not limited to) eating disorders, depression, bipolar disorders, that would be incompatible with safe and successful participation in this study, as determined by investigators
  14. Volunteers with strict dietary concerns (e.g. vegetarian or kosher diet, food allergies) or a reported dislike of a significant fraction of the study foods
  15. Volunteers unwilling or unable to give informed consent
  16. Non-English speakers due to unavailability of required questionnaires in other languages
  17. Resting Energy Expenditure test result within 10% of the 2500 calorie requirement at rest

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 기초 과학
  • 할당: 무작위
  • 중재 모델: 크로스오버 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: low-carbohydrate diet then low-fat diet

A low-carbohydrate followed by low-fat diet, each lasting for 4 weeks in adults with overweight or obesity

Consisting of 15 percent protein, 75 percent fat, and 10 percent carbohydrate

Consisting of 15 percent protein, 10 percent fat, and 75 percent carbohydrate

실험적: low-fat diet then low-carbohydrate diet

A low-fat followed by low-carbohydrate diet, each lasting for 4 weeks in adults with overweight or obesity

Consisting of 15 percent protein, 75 percent fat, and 10 percent carbohydrate

Consisting of 15 percent protein, 10 percent fat, and 75 percent carbohydrate

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in total fat mass
기간: 8 weeks

Change in total fat mass (kg) as measured by dual energy X-ray absorptiometry (DXA) from baseline to week 8

8 weeks

2차 결과 측정

결과 측정
측정값 설명
기간
Rate of body weight change from baseline to week 8
기간: 8 weeks

Rate of body weight change (kg/d) from baseline to week 8

8 weeks
Rate of body weight change during low-carbohydrate diet
기간: Last 2 weeks of low-carbohydrate diet period

Rate of body weight change (kg/d) during the last two weeks of the low-carbohydrate diet

Last 2 weeks of low-carbohydrate diet period
Rate of body weight change during low-fat diet
기간: Last 2 weeks of low-fat diet period

Rate of body weight change (kg/d) during the last two weeks of the low-fat diet

Last 2 weeks of low-fat diet period

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Valerie L Darcey, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2024년 8월 28일

기본 완료 (추정된)

2029년 11월 30일

연구 완료 (추정된)

2029년 11월 30일

연구 등록 날짜

최초 제출

2024년 3월 21일

QC 기준을 충족하는 최초 제출

2024년 3월 21일

처음 게시됨 (실제)

2024년 3월 22일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 2일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 30일

마지막으로 확인됨

2026년 10월 29일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

Body fat and body weight data

IPD 공유 기간

Upon publication in peer reviewed journal

IPD 공유 액세스 기준

Open, general access

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • ANALYTIC_CODE

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다